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Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes among People Living with HIV: A Randomized Controlled Pilot Trial.

ABSTRACT: The purpose of this pilot randomized controlled trial is to assess the feasibility and impact of a triweekly 12-week yoga intervention among people living with HIV (PLWH). Additional objectives included evaluating cognition, physical function, medication adherence, health-related quality of life (HRQoL), and mental health among yoga participants versus controls using blinded assessors. We recruited 22 medically stable PLWH aged ?35 years. A priori feasibility criteria were ?70% yoga session attendance and ?70% of participants satisfied with the intervention using a postparticipation questionnaire. Two participants withdrew from the yoga group. Mean yoga class attendance was 82%, with 100% satisfaction. Intention-to-treat analyses (yoga n = 11, control n = 11) showed no within- or between-group differences in cognitive and physical function. The yoga group improved over time in HRQoL cognition (P = .047) with trends toward improvements in HRQoL health transition (P =.063) and depression (P = .055). This pilot study provides preliminary evidence of feasibility and benefits of yoga for PLWH.

SUBMITTER: Quigley A

PROVIDER: S-EPMC7318828 | biostudies-literature | 2020 Jan-Dec

REPOSITORIES: biostudies-literature

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Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes among People Living with HIV: A Randomized Controlled Pilot Trial.

Quigley Adria A Brouillette Marie-Josée MJ Gahagan Jacqueline J O'Brien Kelly Kathleen KK MacKay-Lyons Marilyn M

Journal of the International Association of Providers of AIDS Care 20200101

The purpose of this pilot randomized controlled trial is to assess the feasibility and impact of a triweekly 12-week yoga intervention among people living with HIV (PLWH). Additional objectives included evaluating cognition, physical function, medication adherence, health-related quality of life (HRQoL), and mental health among yoga participants versus controls using blinded assessors. We recruited 22 medically stable PLWH aged ≥35 years. A priori feasibility criteria were ≥70% yoga session atte ...[more]

PMID: 32583707

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Project description:BACKGROUND:Despite lower mortality rates due to combination antiretroviral therapy, people living with HIV (PLWH) are grappling with increasingly complex health issues, including cognitive impairments in areas such as memory, attention, processing speed, and motor function. Yoga has been shown to be an effective form of exercise and mindfulness-based stress reduction for many clinical populations. However, no randomized trials have evaluated the impact of yoga on cognitive and physical function among PLWH. OBJECTIVE:The aim of this pilot randomized trial was to determine the feasibility of a yoga intervention to lay the groundwork for a full-scale, multisite, community-based trial for PLWH. Specific objectives are to (1) assess the feasibility of study protocol and procedures, (2) compare cognition in the yoga group with the usual care control group after 12 weeks of the intervention in PLWH, and (3) compare the effects of the 12-week yoga intervention versus control on balance, walking speed, physical activity, mental health, medication adherence, and quality of life among PLWH. METHODS:We propose a pilot randomized trial with 2 parallel groups (yoga versus control). We will recruit 25 PLWH (>35 years) from community and health organizations in Halifax, Canada. After baseline assessment with blinded assessors, participants will be randomly assigned to the yoga or control group, using a random computer generator. Participants in the yoga group will engage in supervised 60-min group-based yoga sessions 3 times a week for 12 weeks at a yoga studio. Participants in the control group will maintain their current physical activity levels throughout the study. RESULTS:As per the Consolidated Standards of Reporting Trials extension for pilot studies, means of all outcomes, mean change, and 95% CIs will be calculated for each group separately. Two-tailed independent t tests and Fisher exact tests will be used to compare groups at baseline. We will analyze quantitative postintervention questionnaire responses using Chi-square tests, and open-ended responses will be analyzed thematically. Intention-to-treat and per-protocol analyses will be used to analyze secondary variables. Changes in outcome variables will be examined between groups and within groups. Effect sizes will be reported for each outcome. A priori adherence and satisfaction criteria will be met if participants attend >70% of the yoga sessions and if >70% of the participants are satisfied with the intervention as determined by a postparticipation questionnaire. Study enrollment began in January 2018, with results expected for October 2019. CONCLUSIONS:This pilot randomized trial will be the first to investigate the feasibility and effect of a yoga intervention on cognitive and physical outcomes among PLWH. This work will inform the feasibility of further investigations in terms of capacity building, participant recruitment and retention, and assessment and intervention protocols. TRIAL REGISTRATION:ClinicalTrials.gov NCT03071562; https://clinicaltrials.gov/ct2/show/NCT03071562 (Archived by WebCite at http://www.webcitation.org/785sfhWkw). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/13818.

Project description:BACKGROUND:A significant proportion of older women suffer from chronic pain, which can decrease quality of life. The objective of this pilot randomized study was to evaluate the feasibility of a flow-restorative yoga intervention designed to decrease pain and related outcomes among women aged 60 or older. METHODS:Flow-restorative yoga classes were held twice weekly for 1 hour and led by a certified yoga instructor. Participants randomized to the intervention group attended the yoga classes for 12?weeks and received supplemental materials for at-home practice. Those randomized to the control group were asked to maintain their normal daily routine. Feasibility was evaluated using recruitment and retention rates, class and home practice adherence rates, and participant satisfaction surveys. Outcome measures (self-reported pain, inflammatory markers, functional fitness, quality of life, resilience, and self-reported physical activity) were assessed at baseline and post-intervention. Paired t-tests or Wilcoxon signed-rank tests were used to examine changes in outcome measures within treatment groups. RESULTS:Thirty-eight participants were recruited and randomized. Participants were primarily white, college-educated, and higher functioning, despite experiencing various forms of chronic pain. Attendance and retention rates were high (91 and 97%, respectively) and the majority of participants were satisfied with the yoga program (89%) and would recommend it to others (87%). Intervention participants also experienced reductions in pain interference and improvements in energy and social functioning. CONCLUSIONS:This pilot study provides essential data to inform a full scale randomized trial of flow-restorative yoga for older women with chronic pain. Future studies should emphasize strategies to recruit a more diverse study population, particularly older women at higher risk of disability and functional decline. TRIAL REGISTRATION:Clinicaltrials.gov , NCT03790098 . Registered 31 December 2018 - Retrospectively registered.

Project description:BACKGROUND:As people living with HIV infection require lifelong treatment, nonadherence to medication will reduce their chance of maintaining viral suppression and increase the risk of developing drug resistance and HIV transmission. OBJECTIVE:This study aimed to evaluate the efficacy of a mobile app, Mobile Interactive Supervised Therapy (MIST), for improving adherence to oral HIV medications among HIV-infected adults in Singapore. METHODS:We conducted a two-group pilot randomized controlled trial (RCT) with a process evaluation, in which 40 HIV-infected participants with once-daily medication regimes were recruited from a public tertiary hospital in Singapore and randomly assigned equally to either the intervention (receiving MIST and routine care) or control (receiving routine care only) groups. The intervention lasted for 2 months. The outcome of antiretroviral therapy (ART) adherence was measured by a 7-day recall self-report (SR), pill count (PC), an electronic medical device-Medication Event Monitoring System (MEMS)-and a mobile app-MIST (for the intervention group only). In total, 20 participants from the intervention group were interviewed at the end of the intervention to assess the acceptability of MIST. Data were collected at baseline and at 1-month and 2-month postintervention. RESULTS:All participants had excellent medication adherence at baseline (median 100, IQR 100-100). The use of MIST did not result in a significant improvement in ART adherence when measured by the SR, PC, and MEMS, as compared with the control group at 1-month (P values >.99, .86, and .74, respectively) and 2-month (P values=.80, .84, and .82, respectively) postintervention. ART adherence also did not improve in each group over the same period. MIST was perceived to be a beneficial tool based on the process evaluation results. CONCLUSIONS:Although MIST did not enhance medication adherence to HIV treatments, mainly owing to the ceiling effect, it was perceived to be beneficial among the participants of this study. Our process evaluation provided useful data to further develop MIST for bigger and long-term mobile phone app-assisted intervention RCTs in the future. TRIAL REGISTRATION:ClinicalTrials.gov NCT03794648; https://clinicaltrials.gov/ct2/show/NCT03794648.

Project description:BACKGROUND:Research supports the use of Web-based interventions to promote physical activity in diabetes management. However, previous interventions have found poor levels of engagement or have not included health professionals and people with diabetes in the design of the tool. OBJECTIVE:To develop and explore the feasibility and indicative effect of a Web-based physical activity promotion intervention in people diagnosed with type 2 diabetes living in remote or rural locations. METHODS:A qualitative approach using focus groups that included patients with diabetes and health professionals were run to identify key concepts, ideas, and features, which resulted in the design of a physical activity website. This site was tested using a quantitative approach with a qualitative 6-month pilot study that adopted a three-armed approach. Participants were randomized into three groups: a control group who received written diabetes-specific physical activity advice; an information Web group, a Web-based group who received the information online; and an intervention Web group, an interactive Web-based group who received online information plus interactive features, such as an activity log, personalized advice, and goal setting. RESULTS:A website was designed based on patient and health professional ideas for effective physical activity promotion. This website was tested with 31 participants, 61% (19/31) male, who were randomized into the groups. Website log-ins decreased over time: 4.5 times in month 1, falling to 3 times in month 6. Both the information Web group-mean 134.6 (SD 123.9) to mean 154.9 (SD 144.2) min-and the control group-mean 118.9 (SD 103.8) to mean 126.1 (SD 93.4) min, d=0.07-increased time spent in moderate-to-vigorous physical activity, but this decreased in the intervention Web group-mean 131.9 (SD 126.2) to mean 116.8 (SD 107.4) min. CONCLUSIONS:Access to online diabetes-specific physical information was effective in promoting physical activity in people with type 2 diabetes; access to interactive features was not associated with increases in activity. TRIAL REGISTRATION:International Standard Randomised Controlled Trial Number (ISRCTN): 96266587; http://www.isrctn.com/ISRCTN96266587 (Archived by WebCite at http://www.webcitation.org/6tzX6YesZ).

Project description:IntroductionMiddle East and North Africa (MENA) has a rising rate of new HIV infections and AIDS-related mortality. Consistent adherence to antiretroviral therapy (ART) leads to viral suppression, preventing HIV transmission and treatment failure. mHealth interventions can improve ART adherence by providing tailored support and directing patients to existing healthcare services. HamRaah (Persian for 'together-in-path') is the first mHealth-based intervention in a MENA country and is designed to improve adherence through two-way mobile messaging for people recently diagnosed with HIV in Tehran, Iran. The objectives of this pilot randomised controlled trial (RCT) are to examine the feasibility, acceptability and preliminary effectiveness of HamRaah, and to develop an explanatory theory for any observed effects through a nested realist evaluation.MethodsA feasibility study and two-arm RCT of HamRaah, with an embedded realist evaluation will be conducted. Participants will be randomised 1:1 to HamRaah or routine care for a 6-month intervention. The initial effectiveness of HamRaah will be assessed through the primary outcome of self-reported ART adherence and several secondary outcomes: retention in care, CD4 count and viral suppression. A theory-driven realist evaluation framework will be used to develop an explanatory theory regarding what works, for whom, how and in what context.Ethics and disseminationThe study received ethical clearance from Tehran University of Medical Sciences Ethics Committee and Oxford Tropical Research Ethics Committee People living with HIV in Tehran and key country stakeholders in HIV policy and programming have been involved in the development of HamRaah and this pilot trial. Participants will provide informed consent prior to study enrolment. The results will be disseminated to all stakeholders and presented in peer-reviewed journal publications and conferences.Trial registration numberIRCT20100601004076N23; Pre-results.

Project description:Despite the Mozambique government's efforts to curb human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), national prevalence is 11.5% and support is needed to expand HIV-related services and improve program quality. Positive prevention (PP) programs, which prioritize HIV prevention with people living with HIV and AIDS (PLHIV), have been recognized as an important intervention for preventing new HIV infections. To address this, an evidence-based PP training intervention was implemented with HIV healthcare providers in Mozambique. This study focuses on the acceptability and feasibility of a PP intervention in HIV clinics from the healthcare provider perspective. In-depth interviews were conducted with 31 healthcare providers from three provinces who participated in PP trainings in Mozambique. Interview data were coded using content analysis. Study data suggest that healthcare providers found PP acceptable, feasible to implement in their HIV work in clinic settings, and valued this strategy to improve HIV prevention. The PP training also led providers to feel more comfortable counseling their patients about prevention, with a more holistic approach that included HIV testing, treatment and encouraging PLHIV to live positively. While overall acceptance of the PP training was positive, several barriers to feasibility surfaced in the data. Patient-level barriers included resistance to disclosing HIV status due to fear of stigma and discrimination, difficulty negotiating for condom use, difficulty engaging men in testing and treatment, and the effects of poverty on accessing care. Providers also identified work environment barriers including high patient load, time constraints, and frequent staff turnover. Recognizing PP as an important intervention, healthcare providers should be trained to provide comprehensive prevention, care and treatment for PLHIV. Further work is needed to explore the complex social dynamics and cultural challenges such as gender inequalities, stigma and discrimination which hinder the full impact of PP interventions in this context.

Dataset Information

Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes among People Living with HIV: A Randomized Controlled Pilot Trial.

Publications

Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes among People Living with HIV: A Randomized Controlled Pilot Trial.

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